Bristol Myers Squibb’s Opdivo (nivolumab) has been approved by the U.S. Food and Drug Administration (FDA) for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected stage IIB or IIC melanoma, expanding upon the existing adjuvant indication for Opdivo.
The approval is based on the Phase 3 CheckMate -76K trial, which compared Opdivo (n=526) to placebo (n=264).
In the trial, Opdivo reduced the risk of recurrence, new primary melanoma, or death in patients with completely resected stage IIB or IIC melanoma by 58% compared to placebo (Hazard Ratio [HR] 0.42; 95% Confidence Interval [CI]: 0.30-0.59; P<0.0001). At one year, the recurrence-free survival (RFS) rate was 89% (95% CI: 86-92) for Opdivo versus 79% (95% CI: 74-84) for placebo.
Additionally, in a pre-specified, exploratory subgroup analysis, the RFS unstratified HR was 0.34 (95% CI: 0.20-0.56) in patients with stage IIB melanoma, and 0.51 (95% CI: 0.32-0.81) in stage IIC melanoma patients. One-year RFS rates by stage for patients who received Opdivo were 93% (95% CI: 89–95) in stage IIB versus 84% (95% CI: 77–89) with placebo, and 84% (95% CI: 78–88) in stage IIC versus 72% (95% CI: 62–80) with placebo.
“Following surgical removal of melanoma, patients may believe they are free of disease,” said John M. Kirkwood, M.D., Distinguished Professor of Medicine at the University of Pittsburgh School of Medicine and Co-Director of the Melanoma Center at UPMC Hillman Cancer Center.
“However, within five years of diagnosis, one-third of patients with surgically resected stage IIB and nearly one-half of patients with surgically resected IIC melanoma see their cancer return, underscoring the need for additional treatment options that may help reduce the risk of cancer coming back. The significant recurrence-free survival improvement observed with nivolumab in CheckMate -76K is an important step forward for these patients.”
“Stage IIB and IIC melanoma patients may still face the threat of disease recurrence, despite the benefit of surgery, which can impact outcomes,” said Catherine Owen, senior vice president and general manager, U.S. Cardiovascular, Immunology and Oncology at Bristol Myers Squibb.
“This approval builds on our existing adjuvant indication in completely resected stage III or IV disease and now provides eligible patients with completely resected stage IIB or IIC melanoma an additional treatment option which may help prevent recurrence. BMS remains committed to its goal of helping improve patient outcomes in melanoma and bringing immunotherapy to more patients, including in the earlier stages of disease.”
The FDA previously approved Opdivo for the adjuvant treatment of adult and pediatric patients 12 years and older with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection, based upon data from the CheckMate -238 trial.
Additional CheckMate -76K follow-up data will be presented at the Society for Melanoma Research Annual Meeting in November.
